Device recall: Achieva 1.5T, Model No. 781178, 781196, 781296
Class III FDA enforcement event 93788. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Philips North America started this device recall on 29 Dec 2023. The firm address in the FDA record is in Cambridge, MA. FDA put the recall in Class III. FDA event 93788 has 6 product records. The first FDA enforcement report date is 31 Jan 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.
Recalling firm
Philips North America, Cambridge, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0807-2024 | Achieva 1.5T, Model No. 781178, 781196, 781296 | 7 US; 16 ROW total | Class III | Ongoing | 31 Jan 2024 |
| Z-0808-2024 | Achieva 1.5T Conversion, Model No. 781283 | 7 US; 16 ROW total | Class III | Ongoing | 31 Jan 2024 |
| Z-0809-2024 | Achieva 3.0T, Model No. 781177 | 7 US; 16 ROW total | Class III | Ongoing | 31 Jan 2024 |
| Z-0810-2024 | Ingenia Ambition X, Model No. 782109 | 7 US; 16 ROW total | Class III | Ongoing | 31 Jan 2024 |
| Z-0811-2024 | Intera 1.5T, Model No. 781195 | 7 US; 16 ROW total | Class III | Ongoing | 31 Jan 2024 |
| Z-0812-2024 | SmartPath to dStream for 1.5T, Model No. 781260, 782112 | 7 US; 16 ROW total | Class III | Ongoing | 31 Jan 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class III
- 2%
- Product records in this event
- 6Median of the firm: 2
- Events of the firm on the register
- 30
Other events of the firm
Official channels
- FDA enforcement report Z-0807-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 93788. https://recallregister.com/fda/iii/93788/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.
- What quantity of product is in FDA event 93788?
- The event has 6 product records. The first record gives this quantity:
7 US; 16 ROW total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 2% of the 917 device events that started in 2023 are in Class III.